510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K841513Substantially Equivalent

Scanlan Atraum Instrument Jaw Cover

Scanlan Intl., Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K841513 is the FDA 510(k) clearance record for SCANLAN ATRAUM INSTRUMENT JAW COVER, cleared for Scanlan Intl., Inc. on . FDA records list 19 510(k) clearances for Scanlan Intl., Inc., from to . As of , FDA records show no recalls naming K841513.

Clearance record

Decision date
Received
(85 days to decision)
Review panel
Unknown
Applicant
Scanlan Intl., Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No